Alexithymia, Pain Intensity, Quality of Life, and Psychological Symptoms in Chronic Coccydynia Patients Scheduled for Ganglion Impar Block

NCT07828145 | Not Yet Recruiting

• 1 other identifier: 09.2026.880
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic coccydynia is characterized by pain localized to the coccygeal region that typically worsens with sitting, leading to notable impairments in functional performance and health-related quality of life. In clinical practice, fluoroscopy-guided Ganglion Impar Block (GIB) is commonly performed as an interventional treatment in patients unresponsive to conservative medical therapies. Alexithymia, defined as a multidimensional personality construct involving difficulty identifying and describing feelings alongside an externally oriented thinking style, has been shown to be prevalent in chronic pain conditions and associated with pain intensity, mood symptoms, and functional disability. The primary objective of this prospective analytical cross-sectional study is to examine the relationship between alexithymia levels (evaluated via the 20-item Toronto Alexithymia Scale \[TAS-20\]) and pain intensity, health-related quality of life, anxiety, depression, and childhood trauma in patients with chronic coccydynia who are scheduled to undergo Ganglion Impar Block based on routine clinical indications.

Conditions

Coccydynia; Chronic Pain; Alexithymia

Keywords

Ganglion Impar Block; Coccydynia; Alexithymia; TAS-20; Quality of Life; Hospital Anxiety and Depression Scale; Childhood Trauma

Outcome Measures

Primary Outcomes (1)

• 20-Item Toronto Alexithymia Scale (TAS-20) Total Score

  The TAS-20 is a self-report questionnaire used to assess the severity of alexithymia. It contains 20 items scored on a 5-point Likert scale ranging from 1 to 5. The total score ranges from 20 to 100, where higher scores indicate greater alexithymia severity. Established cut-off scores: ≤51 indicates non-alexithymia, 52 to 60 indicates possible alexithymia, and ≥61 indicates alexithymia.

  Baseline (immediately prior to the Ganglion Impar Block procedure)

Secondary Outcomes (4)

• Pain Intensity Measured by Visual Analog Scale (VAS)

  Baseline (immediately prior to the Ganglion Impar Block procedure)

• Hospital Anxiety and Depression Scale (HADS) Scores

  Baseline (immediately prior to the Ganglion Impar Block procedure)

• Health-Related Quality of Life Measured by 12-Item Short Form Survey (SF-12)

  Baseline (immediately prior to the Ganglion Impar Block procedure)

• Childhood Trauma Questionnaire (CTQ-33) Total Score

  Baseline (immediately prior to the Ganglion Impar Block procedure)

Study Arms (1)

Chronic Coccydynia Patients

Adult patients aged 18 years or older diagnosed with chronic coccydynia for at least 3 months, who are scheduled to undergo fluoroscopy-guided Ganglion Impar Block due to persistent pain despite conservative treatments.

Other: Psychometric and Clinical Survey Battery

Interventions

Psychometric and Clinical Survey Battery OTHER

Cross-sectional pre-procedural assessment consisting of self-report questionnaires administered immediately prior to the Ganglion Impar Block procedure. The battery includes the 20-Item Toronto Alexithymia Scale (TAS-20), Visual Analog Scale (VAS 0-10 cm), Hospital Anxiety and Depression Scale (HADS), 12-Item Short Form Health Survey (SF-12), and Childhood Trauma Questionnaire (CTQ-33), alongside a structured sociodemographic data form.

Chronic Coccydynia Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting to Marmara University Pendik Training and Research Hospital, Division of Algology outpatient clinic, who are diagnosed with chronic coccydynia and scheduled for clinically indicated Ganglion Impar Block.

You may qualify if:

• Age 18 years or older.
• Clinical diagnosis of chronic coccydynia persisting for at least 3 months.
• Clinical indication and scheduled for Ganglion Impar Block due to persistent pain refractory to conservative treatments.
• Literate and possessing sufficient mental capacity to comprehend and complete self-report instruments.
• Provision of voluntary written informed consent.

You may not qualify if:

• Significant cognitive impairment or communication barriers impairing informed consent capacity or questionnaire completion.
• Active psychotic disorder or current manic episode.
• Suspected acute self-harm or suicidal risk identified during clinical evaluation.
• Chronic coccygeal pain secondary to malignancy, acute fractures, or active infection.
• Severe active psychiatric disease currently under medical treatment (e.g., severe mental illness, schizophrenia, bipolar affective disorder).

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain; Affective Symptoms; Depression

Interventions

Psychometrics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

OSMAN H GÜNDÜZ, MD, Prof.

CONTACT

+90 216 657 06 06; gunduzh@marmara.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

TU (1)